Pharma and Life Sciences
Improving RoI on emerging market registrations
11 Aug 2023
Over the last few years, Indian pharma companies have faced quite a bit of headwind in the US generics market due to increasing competitive intensity and supplier consolidation. Quality issues have also moderated their growth in the US market. This has led to a renewed focus on emerging markets. Owing to the increasing salience of revenue from US and European products, many of the larger Indian pharmaceutical companies have focused on developing systemic capabilities to develop, file and launch products on time. However, the product registration process and launches in emerging markets are equally complex, which need to be addressed to increase the salience and bring predictability of revenues from this segment.
The complexity in product registrations is primarily due to:
Compared to the US and European markets, the number of filings is very high and can vary in number from high double digits to 100-200 per year. The sheer number of filings inherently increases the complexity of managing the registration process.
Along with the higher number of registrations, for the same product, requirements vary across countries notwithstanding the differing timelines for approvals which can go up to 2 years. While some products require testing in local laboratories, others may require BA/BE tests as well, or there can be variations in the data requirements. Maintaining, executing, and tracking across multiple markets presents a huge challenge.
While it is a given that processes with a company will involve multiple stakeholders, in case of emerging markets based on chosen GTM strategies, companies may have to file through local distributors or through local agents. Further, many regulatory bodies mandate that the filings be made in the local language. Engaging, managing, and ensuring the timely completion of these activities induces another dimension of complexity.
While companies do set targets for registrations, many times they fall short of it as they do not understand their own capacity in terms of how many filings their team can do across markets considering all the dossier preparation activities by both internal and external stakeholders.
Such challenges when unaddressed typically result in delays in filings, delays in responses to regulators, and finally deferment of revenue which is nothing but loss of revenue that can turn out to be significant. Addressing these challenges can prevent revenue losses amounting to 20-30% of new product revenue. Along with the revenue loss, a significant amount of manpower needs to be deployed to address the over-runs.
Pharma companies can proactively prevent revenue loss by taking a project management approach for new product registrations in emerging markets which should be enabled by a dedicated team to manage the whole process. The project management approach should be further supported by mapping out all the requirements for each country, estimating the capacity of the team to deliver, and last but not the least endeavoring to drive efficiencies in the whole process across all the relevant stakeholders.